A5202, FINAL VERSION 10, 05/05/05: INITIAL THERAPY WITH DIFFERENT ANTIRETROVIRA

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这是一项iii期、随机、部分盲法研究，比较了四种ARV治疗方案的疗效、安全性和耐受性：ARM a: EFV 600 mg QD + FTC 200 mg/TDF 300 mg QD + ABC/3TC安慰剂QD； ARM B: EFV 600 mg QD + ABC 600 mg/3TC 300 mg QD + FTC/TDF安慰剂QD； ARM C: ATV 300 mg QD + RTV 100 mg QD + FTC 200 mg/TDF 300 mg QD + ABC/3TC安慰剂QD；ATV 300 mg QD + RTV 100 mg QD + ABC 600 mg/3TC 300 mg QD + FTC/TDF安慰剂QD符合条件的受试者将是ARV药物初始（入组前任何时间ARV治疗<天*），并在入组前90天内获得血浆HIV-1 RNA bbb1000拷贝/ml。没有CD4+ t细胞计数限制。*唯一的例外是：(1)使用抗病毒药物作为暴露后预防（PEP）的一部分，前提是受试者在需要PEP的事件中没有感染HIV-1。(2)使用非NRTI、NNRTI或PI的研究性ARV药物进行治疗。1800名受试者（每个研究组450名）将在大约96周的时间内入组。受试者将根据筛选时的HIV-1 RNA水平（<100,000拷贝/ml vs >100,000拷贝/ml）以及入组代谢亚研究A5224s的意向和资格进行分层。在最后一名受试者入组后，受试者将被随访约96周。该研究已获得IND豁免地位。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a phase IIIB, randomized, partially blinded study comparing the efficacy, safety, and tolerability of four ARV regimens: ARM A: EFV 600 mg QD + FTC 200 mg/TDF 300 mg QD + ABC/3TC placebo QD ARM B: EFV 600 mg QD + ABC 600 mg/3TC 300 mg QD + FTC/TDF placebo QD ARM C: ATV 300 mg QD with RTV 100 mg QD + FTC 200 mg/TDF 300 mg QD + ABC/3TC placebo QD ARM D: ATV 300 mg QD with RTV 100 mg QD + ABC 600 mg/3TC 300 mg QD + FTC/TDF placebo QD Eligible subjects will be ARV drug-naive (< days of ARV treatment at any time prior to entry*) with plasma HIV-1 RNA >1000 copies/ml obtained within 90 days prior to study entry. There will be no CD4+ T-cell count restriction. *The only exceptions are: (1)Use of antivirals as part of post-exposure prophylaxis (PEP) provided the subject did not acquire HIV-1 infection fkom the event that required PEP. (2) Therapy with an investigational ARV drug that was not an NRTI, NNRTI, or PI. 1800 subjects (450 per study arm) will enroll over approximately 96 weeks. Subjects will be stratified by HIV-1 RNA level at screening (<100,000 copies/ml versus >100,000 copies/ml) and intent and eligibility to enroll in the metabolic substudy A5224s. Subjects will be followed for approximately 96 weeks after the last subject is enrolled. This study has been granted IND exempt status.